Lupin Pharmaceuticals Recalls Four Lots of Quinapril

Lupin Pharmaceuticals has recalled four lots of its blood pressure medication Quinapril because of the potential presence of a nitrosamine impurity, N-Nitroso-Quinapril.

The affected drugs include one lot of 20mg tablets and three lots of 40 mg tablets. The company ongoing testing found the impurity above the FDA’s Acceptable Daily Intake level of 26.5 nanograms per day.

Exposure to nitrosamines at unacceptable levels over time can increase cancer risk. The FDA estimates that a daily lifelong total intake of nitrosamines at 96 nanograms per day is an acceptable intake.

The company stopped marketing the Quinapril tablets in September.